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Author Topic: Deep brain stimulator - Speech  (Read 85840 times)
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dennis100
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« Reply #150 on: January 20, 2014, 01:02:05 PM »

Model Number 7428
Device Problems Loss of power; Implant, reprogramming of
Event Type  Malfunction 
Event Description
It was reported that the pt experienced a loss of therapeutic effect and their jaw almost locked up and experienced speech and swallowing difficulties. Some of the pt's dystonia symptoms, specifically rigidity in their left hand returned. Add'l info rec'd reported that the pt's neurostimulator turned off and when power was restored, it was on an incorrect program. Reprogramming indicated that voltages had increased. Good results were observed with reprogramming. No injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1478820
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dennis100
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« Reply #151 on: January 20, 2014, 01:39:25 PM »

Device Problems Other (for use when an appropriate device code cannot be identified); No Known Device Problem
Event Date 06/20/2009
Event Type  Injury   Patient Outcome  Other
Event Description
Literature: okun ms, fernandez hh, wu ss, et al. Cognition and mood in parkinson's disease in subthalamic nucleus versus globus pallidus interna deep brain stimulation: the compare trial. Ann neurol. 2009;65(5):586-595. Summary: the study was a single-center, prospective, randomized, patient-and rater-blind, parallel-group trial that aimed to characterize and compare the effects of unilateral stn and unilateral gpi dbs on mood and cognitive function in patients with advanced pd. All patients were recruited, and 10 patients did not pass initial screening. A total were randomized to stn or gpi dbs. A total patients completed the study. Reportable event: some cases of difficulty with speech and language/increased speech were reported. Symptoms occurred in both implant locations (stn and gpi). Two cases were noted to be serious. No treatment or outcome was reported. A worsening of letter verbal fluency (hoehn and yahr stage of four or higher) was seen in an unspecified number of patient's with lead implanted in the stn verses pre-dbs. The deterioration was noted in optimal, dorsal, and especially off dbs conditions. The persistence of the deterioration in the off dbs state suggested a surgical rather than stimulation-induced effect. See literature article attached to mfr report # 2182207-2009-05291.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1432285
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dennis100
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« Reply #152 on: January 21, 2014, 03:21:57 AM »

Model Number 7428
Event Date 01/01/2009
Event Type  Malfunction 
Event Description
The pt was pulled by a speed boat while sitting on an inflatable chair. The ride was jarring. Afterward, the pt felt unconformable. Her left hand was going into spasm and her tongue was twisting, making it difficult for her to speak. The pt felt disoriented. Interrogation with the pt programmer revealed that the amplitude of the deep brain stimulator unit was set to 1. 6 and 1. 1 volts. Prior to the ride it was 0. 5 and 0. 6 volts. The upper limit of stimulation was set to 1. 0 volt. The pt's condition had returned to normal once the device amplitude was turned back down. The pt had pain in her neck where the wires were. The pt had not had problems with her deep brain stimulator after participating in water sports before.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1521807
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dennis100
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« Reply #153 on: January 22, 2014, 09:19:03 AM »

Model Number 7428
Device Problems Device operates differently than expected; Impedance issue
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported, the pt was moving very slowly. There was a problem with the impedance values. The pt was referred for a consult and possible adjustment. Add'l info received indicated, the event was suspected to be attributed to the location of the lead. The cause of the event was unclear; but may be related to the programmed settings. The pt experienced cognitive changes, flat affect, and symptoms of early dementia. Reprogramming was done. A contact was deleted in the superior zona incerta region to improve the patient's gait. A prescription for galantamine was added. Office notes indicated, the pt festinated in small spaces. The pt had fallen, however, walked ok when out and about. In 2009 at the time of the visit, the pt had a good long stride, good bilateral arm swing, fair balance on pull testing. The pt was very hypophonic. Contact 7 was deleted during programming, as the pt may have had worsening of his gait from this contact. It was initially added to control stim related dyskinesias, but perhaps those had since resolved or were less bothersome. It was reported over the last 9 months, the pt had multiple falls (>15). The pt reported having difficulty moving around for quite awhile, however, it had gotten to the point his feet buckle and he can't regain balance and falls over if there is nothing to catch him. The patient denied any precipitating factors or patterns. The pt denied any lightheadedness, dizziness, palpitations, mental lapses, loss of consciousness, or feelings of weakness associated with the falls. The pt reportedly broke a ribe during one of the falls and that he temporarily lost consciousness (10 seconds) during another episode where he fell in a parking lot. The pt had no residual pain/problems related to the falls. The pt also presented with worsening cognitive decline. The pt and his wife believed his memory was declining and he got confused easily, both of which had gotten progressively worse for the last 6-8 months. The pt had a "depressive mood" which was being treated with venlafaxine, which his wife describes as a lack of motivation. The pt reported he "feels terrible" but was unable to describe the symptoms further. Along with his wife, the pt questioned if it was related to worsening pd or if this was a new problem. No functional problems were reported with the dbs unit, however, a technician had indicated the unit was not working as "efficiently as it could. " the pt's cognitive symptoms were consistent with the onset of dementia seen in pd. Given the new onset, the pt was recommended to start on galantamine and monitor for response. The pt also underwent changes to medications for the depressive symptoms. Medications: sinemet, venlafaxine, allopurinal, asa, simvastatin, lisinopril, vit b12, docusate.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1580214
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dennis100
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« Reply #154 on: January 25, 2014, 03:07:06 PM »

Model Number 37601
Device Problem Impedance issue
Event Date 07/28/2010
Event Type  Malfunction 
Event Description
A physician reported low impedances readings on all bipolar pairs between 8-11, which read 95-97 ohms. On left side, pt had normal range case combos (tested at 0. 7v): c-8=635, c-9=638, c-10=635 and c-11=637 ohms. Pt was just implanted in june but this was his first programming session. The physician was able to reprogram the pt, but is concerned with the high current use given current programming and low impedance on the left side. Pt left the office with 8-, 9-, and 10+ and was getting good tremor relief and was happy with the results. Physician left pt at 2v and gave him 2 groups, one for when he needs to talk more and one that controls his tremor more, but interferes more with his speech. Ins was currently at 2. 99v. Pt did not report any shocking or unusual stimulation during programming sessions. Physician thought he would bring the pt back into the office to assess therapy impedances and check how pt is doing. Add'l info has been requested and if rec'd a f/u report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1824899
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« Reply #155 on: January 25, 2014, 03:08:05 PM »

Model Number 7426 NEUROSTIMULATOR
Event Date 07/14/2010
Event Type  Injury   Patient Outcome  Other
Event Description
Stroke surrounding the right sided stimulator. On (b)(6) 2010, pt had implantation of bilateral dbs for dystonia. Upon awakening the evening of surgery, the pt experienced facial drooping and problems with understanding her speech. On (b)(6) 2010, symptoms continued and she progressively had problems with putting sentences together, talking very slowly, and had difficulty understanding what was being said to her. On (b)(6) 2010, she developed left hemiparesis. Pt was transferred to rehab unit on (b)(6) 2010 and discharged home with mother on (b)(6) 2010. Upon discharge, pt was full transfer alone and one handheld assist with gait due to impulsivity and poor motor planning. Clinically, pt was nearly back to baseline. Pt will be scheduled for outpatient therapy if needed. F/u info 07/27/2010: all motor symptoms from stroke have resolved. Family reports cognition is at baseline and possibly better than prior to implants.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1913087
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dennis100
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« Reply #156 on: January 26, 2014, 01:41:22 AM »

Model Number IPGNEURO
Device Problems Fracture; Device Issue; Positioning Issue
Event Date 08/01/2010
Event Type  Death   Patient Outcome  Death,Required Intervention
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. The pt info provided in section a is the average for all the pts. At this time, no add'l info was available, add'l info has been requested.

 
Event Description
Literature: burdick ap, fernandez hh, okun ms, chi yy, jacobson c, foote kd. Relationship between higher rates of adverse events in deep brain stimulation using standardized prospective recording and pt outcomes. Neurosurg focus. Aug 2010;29(2):e4. Summary: the authors disclose the standardized and prospectively recorded ae data from their institution between (b)(6) 2002 and (b)(6) 2008. Two hundred seventy dbs procedures were performed in 198 pts; 26 pts had dystonia, 43 had essential tremor, 113 had parkinson disease, 6 had ocd, and 10 had other causes of tremor. The dbs leads were implanted on the left hemisphere in 133 procedures, on the right in 88, and bilaterally in 49. A total of 300 aes were recorded in 146 of the 270 procedures, and the aes were recorded in 119 of 198 pts. No significant qol differences. Event: the frequency of the 300 adverse events were as follows: mental status decline 53, other (unspecified) 43, gait problem 21, other motor problem 20, seizure 16, ich (symptomatic) 16, lead misplacement 15, speech-aphasia 13, speech-dysarthria 11, subdural/other bleed 11, mania/hypomania 8, infection, deep (hardware removal) 7, air embolus 6, speech-hypophonia 6, depression 6, infection, deep (revision, iv antibiotics) 5, swallow problem 5, anxiety 5, incontinence 4, visual problem 4, infection, superficial (oral antibiotics) 4, hardware malfunction (other) 4, death 2, hardware malfunction (fracture) 2, hydrocephalus 2, neurological deficit (other) 2, stroke 2, scalp erosion 2, suicidal ideation 2, ipg seroma 1, other sensory problem 1 and psychogenic disorder 1. See attached literature article.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885229
« Last Edit: February 03, 2014, 03:08:31 AM by dennis100 » Logged
dennis100
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« Reply #157 on: January 27, 2014, 02:43:47 AM »

Model Number 37602
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
It was reported the patient programmer showed eri today. It was also reported the patient had been having an increase in spasms, see floaters or spots for visions, and losing her balance since (b)(6) 2013. Speech issues were also noted. Additional information received from the health care provider reported that the cause of the event was an "expiring left implantable neurostimulator (ins). " it was stated that the ins battery depletion was "normal. " there were no abnormal impedance measurements. It was stated that the ins was replaced on (b)(6) 2013. It was stated that the patient did require hospitalization and that it was an "outpatient procedure. " the patient outcome was reported at "no injury. ".

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3512883
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« Reply #158 on: January 28, 2014, 09:16:09 AM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 04/27/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: denys d, mantione m, figee m, et al. Deep brain stimulation of the nucleus accumbens for treatment-refractory obsessive-compulsive disorder. Arch gen psychiatry. Oct 2010;67(10): 1061-1068. Summary: the authors conducted a double-blind, sham-controlled trial to demonstrate that bilateral stimulation of the nucleus accumbens can be an effective and safe treatment in treatment-refractory pts with obsessive compulsive disorder (ocd). All pts underwent electrode implantation in the same target area, and stimulation settings were applied uniformity throughout the study. During the treatment period of 21 months, obsessive-compulsive symptoms decreased by 52%, and 9 of 16 pts responded, with a mean improvement of 72%. Anxiety and depressive symptoms decreased by half. The surgical procedure and stimulation were well tolerated. Permanent adverse events were limited to mild forgetfulness and word-finding problems. Increased libido was reported by several pts but may be interpreted as a return to normal functioning rather than an adverse event. Reportable event: one pt, ((b)(6) female), experienced a wound infection and numbness at the incision site. This pt also experienced tiredness, paresthesias in the hands and feet and hypomanic symptoms. The hypomania or elevated mood occurred shortly after the switch of the contact points from 0 or 1 to 2 or 3 and lasted for 2 days. Elevated mood or hypomania never required the addition of a mood stabilizer, and the adverse event was rated as mild. Elevated mood was frequently reported during reactivation of the stimulation after an off period. For this pt, the effect of stimulation was not subjectively noticeable. See literature article with mfr report# 3007566237201010486.

 
Manufacturer Narrative
(b)(4) (paresthesias of the hands and feet). At this time no additional info was available, additional info has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1939551
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« Reply #159 on: February 06, 2014, 11:01:16 PM »

Model Number NEU_INS_STIMULATOR
Event Date 07/31/2013
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Hung, h. Y. , tsai, s. T. , lin, s. H. , jiang, j. L. , chen, s. Y. Uneven benefits of subthalamic nucleus deep brain stimulation in parkinson's disease-a 7-year cross-sectional study. Tzu chi medical journal. 2013;25(4):239-245. Doi: 10. 1016/j. Tcmj. 2013. 08. 003. Summary: subthalamic nucleus deep brain stimulation (stn-dbs) for motor symptoms of parkinson¿s disease (pd) is promising. However, the benefits of stn-dbs are uneven for the cardinal motor symptoms, as well as for mentality and activities of daily living as the disease progresses. In this report, we will try to clarify which target symptoms have long-term effects during 7 years of stn-dbs. From february 2002 to february 2011, 120 pd patients who underwent stn-dbs were enrolled in this cross-sectional study. Data analysis was performed at postoperative follow-up periods of 1 year, 2 years, 5 years, and 7 years. The unified parkinson's disease rating scale (updrs) was evaluated in four combinations of levodopa/dbs, on/off. With levodopa off/dbs on, the updrs part iii score improved significantly within the 7 years of follow-up (p <(><<)> 0. 001). Decrements in the degree of improvement in axial symptoms were observed after the 5th year. Despite significant improvement in the updrs part ii during the 7 years of follow-up, the score of the schwab and england activities of daily living scale declined after the 5th year of dbs. With levodopa off/dbs off, the scores for part iii and all subitems deteriorated in comparison with the preoperative levodopa off score after the 5th year of follow-up. Bradykinesia was significantly worse in the 5th and 7th years (p <(><<)> 0. 05 and p <(><<)> 0. 01, respectively) and the axial component was significantly worse in the 7th year (p <(><<)> 0. 05). Stimulation side effects included hypophonia (20. 8%), dysarthria (15%), sialorrhea (14. 2%), and decreased memory (14. 2%). Other surgically related adverse effects included intracranial hemorrhage (3. 3%), pulmonary edema (n ¼ 3), deep vein thrombosis (n ¼ 1), seizure (n ¼ 1), depression (n ¼ 7), and mania/hypomania (n ¼ 11). Five electrodes were revised and two devices became infected. Dbs stimulation parameters remained stable except for a significant reduction in frequency in the 7th year. Long-term effects of dbs on motor disability are promising. Dbs showed uneven beneficial effects, and least improvement in axial symptoms and verbal fluency. The disease progressed despite significant positive effects of dbs on the cardinal motor disability symptoms of pd and quality of life at 7 years. Reported events: 1. 1 patient with parkinson¿s disease experienced a symptomatic intracranial hemorrhage and only made a partial recovery. 2. 1 patient with parkinson¿s disease experienced a symptomatic intracranial hemorrhage and made a total recovery. 3. 2 patients with parkinson¿s disease experienced an asymptomatic intracranial hemorrhage. 4. 1 patient with parkinson¿s disease experienced seizures following stn dbs. The reporter stated that the patient recovered well. 5. 1 patient with parkinson¿s disease had an infection of the hardware. It was noted that the device required explant. 6. 1 patient with parkinson¿s disease had an infection of the hardware. It was noted that the device did not require explant. 7. 3 patients with parkinson¿s disease experienced pulmonary edema following stn dbs. The reporter stated that the patients recovered well. 8. 4 patients with parkinson¿s disease had a unilateral lead that was sub-optimally placed and needed to be repositioned. 9. 1 patient with parkinson¿s disease had bilateral leads that were sub-optimally placed and needed to be repositioned. 10. 6 patients with parkinson¿s disease had a wire revision. 11. 2 patients with parkinson¿s disease had battery failure. The reporter stated that the patients had standard stimulation parameters and experienced early termination of the implantable neurostimulator (ins) battery. 12. 1 patient with parkinson¿s disease experienced implantable neurostimulator (ins) migration. 13. 5 patients with parkinson¿s disease experienced lead problems. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3600825
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« Reply #160 on: February 07, 2014, 12:23:32 AM »

Model Number 37612
Event Date 12/31/2013
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# va0a55s, implanted: 2013 (b)(6); product type lead product id 3387s-40, lot# va0a55s, implanted: 2013 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension (b)(4).

 
Event Description
It was reported, the patient had one side of the deep brain stimulator (dbs) turned on 2013 (b)(6) and the patient was doing ¿very very well¿ and they could understand when the patient talked and the patient could talk perfectly. It was stated, the patient¿s second side was turned on 9 days prior to report and ever since then the patient had problems. It was noted, the patient was stumbling and they used a walker to help them and they had an awful time navigating. It was stated, the patient would babble. It was noted it was hard to understand the patient. It was stated, the patient would babble and it ¿was like the patient had a stroke. ¿ it was stated they did not think the patient had a stroke. It was stated when the second side was turned on the patient fell at the health care professional¿s office. It was stated, the patient was weak and falling again. It was noted, the stimulation was turned down until the patient felt better and steadier on their feet and would not stumble. It was noted, the patient programmer did not have the ability to increase stimulation but only decrease. It was further reported, the cause of the event was possible effect of the programmer 1-2 weeks after the patient was seen. It was stated, the patient had fallen and tore their rotator cuff. It was noted, the patient fell 1-2 weeks after reprogramming of the dbs. It was stated, the patient was ¿all over the place¿ with movements on their right side and problems with speech, balance, and hallucinations. It was stated, the patient as seen by their family physician on 2014 (b)(6) who had questioned whether it was untoward affect from dbs and or the medication. It was stated, the patient¿s left side settings were decreased. It was noted, the patient¿s medication was also discontinued. It was stated no x-rays were performed. It was noted, the patient as to be seen on the day of report for reprogramming but it was cancelled due to poor weather. It was stated, the wife had rescheduled the appointment for 2014 (b)(6). It was noted the symptoms of jerky movement and affected speech had resolved. It was stated symptoms associated with the event were hyper-movement of left side, speech decreased, and hallucinations. It was stated, the patient sustained torn rotator cuff after fall. It was noted, the patient outcome was non-serious injury or illness. It was stated 2014 (b)(6), the patient was doing well. It was stated, the patient was able to feed themselves. It was stated the patient dressed with minimal assistance and they could put their jeans on. It was noted their speech improved and they were mentally clear. It was stated the patient had a walker that they would use inconsistently.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3595012
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« Reply #161 on: February 07, 2014, 08:35:04 AM »

Model Number NEU_INS_STIMULATOR
Event Date 09/04/2012
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization,Disability
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, lot# unknown product type: lead. Product id: neu_unknown_ext, lot# unknown product type: extension. (b)(4).

 
Event Description
It was reported there was a concomitant left basal ganglia intracerebral hemorrhage (1 x 2cm) that surrounded the left deep brain stimulation (dbs) lead. It was noted intervention included medical or non-surgical therapy. It was stated there was a ct scan without contrast. It was noted the results were expected post-operative pneumocephalus and no new hemorrhage was identified on (b)(6) 2012. It was noted on (b)(6) 2012 another ct scan without contrast was performed and the hemorrhage around the tip of the left dbs was unchanged. It was stated an eeg was performed and the results were independent right and left frontotemporal irregular delta slowing, frontal intermittent rhythmic delta activity which was suggestive of a mild to moderate non-specific cerebral dysfunction on (b)(6) 2012. It was noted an eeg with video suggested dysfunction in the left hemisphere. It was stated on (b)(6) 2012 a ct scan without contrast was performed and the results showed the pneumocephalus had resolved and there was a continued evolution of intraparenchymal hemorrhage that was centered around the left dbs lead and no hemorrhage was seen. Etiology consisted of surgery and anesthesia. It was noted it was not related to the device or therapy but it was possibly related to the implant procedure. It was noted the patient had weakness on right upper extremity and aphasia with a decline in respiratory rate and it was severe. It was noted the event resulted in in-patient hospitalization and prolonged existing hospitalization and persistent or significant disability/incapacity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3591800
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« Reply #162 on: February 07, 2014, 08:37:28 AM »

Model Number NEU_INS_STIMULATOR
Event Date 08/01/2013
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
Claeys, i. , santens, p. , van den abbeele, d. , van roost, d. , lemmens, g. M. D. A manic episode after bilateral subthalamic stimulation in a patient with advanced parkinson's disease. Acta neuropsychiatrica. 2013;25(6):367-369. Doi: 10. 1017/neu. 2013. 30 summary: deep brain stimulation (dbs) has proven to be an effective treatment for patients with refractory symptoms in the advanced stages of parkinson¿s disease. However, different psychiatric and cognitive problems may occur after dbs. We report a case of a manic episode after dbs of the subthalamic nucleus in a patient with advanced parkinson¿s disease. After slow and gradually restart of the neurostimulation using the lowest effective intensity, the motor symptoms remained sufficiently under control without causing any psychiatric problems. Reported events: one (b)(6) old male patient with parkinson¿s disease was treated with deep brain stimulation (dbs) of the subthalamic nucleus (stn). The reporter stated that the patient¿s surgery had gone well and the patient¿s motor symptoms had markedly improved following stimulation at 2 volts. Four weeks after implant, the patient was reportedly urgently admitted to the hospital with important behavioral changes. It was noted that the patient was not able to sleep at night and only slept 1-2 hours during the daytime. The patient¿s mood was reportedly elevated and had logorrhea. The reporter stated that the patient¿s behavior was impulsive and disinhibited, as the patient was ¿buying lots of things¿ and ¿making inappropriate sexual comments. ¿ the reporter stated that the patient¿s psychomotor activity was increased and the patient was agitated. The patient also reportedly had grandiose ideas. The patient reportedly had no insight in the behavioral changes and felt ¿fantastic. ¿ it was noted that there were no hallucinations or suicidal ideas present. It was reported that following the initial discharge from the hospital, the patient had only slept for four hours per night and his mood was ¿a bit elevated but not problematic. ¿ it was noted that this was initially ascribed to the patient¿s feelings of relief after the surgical procedure. The reporter stated that the patient was diagnosed with a manic episode ¿probably elicited by dbs. ¿ the dbs was then turned off and the patient¿s motor symptoms, including rigidity and camptocormia rapidly re-appeared but all behavioral changes disappeared. The reporter stated that dbs was again initiated and gradually but more slowly increased to 1. 5 volts bilaterally. The reporter stated that this stimulation sufficiently controlled the motor symptoms without causing any behavioral problems and any need for further anti parkinson medication. It was noted that the patient was given 100mg daily trazodone for sleep difficulties. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3585639
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« Reply #163 on: February 07, 2014, 08:38:27 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/19/2013
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Issar, n. M. , hedera, p. , phibbs, f. T. , konrad, p. E. , neimat, j. S. Treating post-traumatic tremor with deep brain stimulation: report of five cases. Parkinsonism <(>&<)> related disorders. 2013;19(12):1100-1105. Summary: post-traumatic tremor is one of the most common movement disorders resulting from severe head trauma. However, literature regarding successful deep brain stimulation (dbs) treatment is scarce, resulting in ambiguity regarding the optimal lead location. Most cases support the ventral intermediate nucleus, but there is evidence to defend dbs of the zona incerta, ventral oralis anterior/ posterior, and/or a combination of these targets. We report five patients with disabling posttraumatic tremor treated with dbs of the ventral intermediate nucleus and of the globus pallidus internus. Patients were referred to the vanderbilt movement disorders division, and surgical intervention was determined by a dbs multidisciplinary committee. Standard dbs procedure was followed. Patients 1e4 sustained severe diffuse axonal injuries. Patients 1e3 underwent unilateral ventral intermediate nucleus dbs for contralateral tremor, while patient 4 underwent bilateral ventral intermediate nucleus dbs. Patients 1e3 experienced good tremor reduction, while patient 4 experienced moderate tremor reduction with some dystonic posturing of the hands. Patient 5 had dystonic posturing of the right upper extremity with tremor of the left upper extremity. He was treated with bilateral dbs of the globus pallidus internus and showed good tremor reduction at follow-up. Unilateral or bilateral dbs of the ventral intermediate nucleus and bilateral dbs of the globus pallidus internus may be effective and safe treatment modalities for intractable post-traumatic tremor. Further studies are needed to clarify the optimal target for surgical treatment of post-traumatic tremor. Reported event: one (b)(6) male patient with deep brain stimulation (dbs) for post-traumatic tremor experienced moderate tremor reduction with some dystonic posturing of the hands. The reporter stated that the patient experienced stimulation-associated side effects including some dystonia movements of the upper extremities, gait instability, balance difficulties, paresthesias, ataxia while walking, and slurred speech. The reporter stated that the patient experienced decreased tremor control and increased impedance between six and 33 months after dbs implantation. It was noted that the patient underwent exploration and interrogation of the dbs system with replacement of the extension wires, which resulted in significantly improved tremor reduction. The patient reportedly continued to have some dystonic posturing of both hands while performing fine motor tasks. The reporter stated that the continued dystonic side effects may require consideration of additional leads in the globus pallidus internus (gpi) for increased tremor reduction. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3571891
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« Reply #164 on: February 07, 2014, 08:40:32 AM »

Model Number NEU_INS_STIMULATOR
Event Date 02/07/2013
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_ins_stimulator, serial # unknown, product type: implantable neurostimulator. (b)(4).

 
Event Description
Morishita, t. , okun, m. S. , burdick, a. , jacobson, iv c. E. , foote, k. D. 2013. Cerebral venous infarction: a potentially avoidable complication of deep brain stimulation surgery. Neuromodulation 2013; 16: 407¿413. Doi: 10. 1111/ner. 12052 summary: despite numerous reports on the morbidity and mortality of deep brain stimulation (dbs), cerebral venous infarction has rarely been reported. We present four cases of venous infarct secondary to dbs surgery. The diagnosis of venous infarction was based on delayed onset of new neurologic deficits on postoperative day 1 or 2; significant edema surrounding the superficial aspect of the implanted lead, with or without subcortical hemorrhage on ct scan. Four cases (0. 8% per lead, 1. 3% per patient) of symptomatic cerebral venous infarction were identified out of 500 dbs lead implantation procedures between july 2002 and august 2009. All four patients had parkinson¿s disease. Their dbs leads were implanted in the subthalamic nucleus (n = 2), and the globus pallidus internus (n = 2). Retrospective review of the targeting confirmed that the planned trajectory passed within 3mm of a cortical vein in two cases for which contrast-enhanced preoperative magnetic resonance (mr) imaging was available. In the other two cases, contrasted targeting images were not obtained preoperatively. Cerebral venous infarction is a potentially avoidable, but serious complication. To minimize its incidence,we propose the use of high-resolution, contrast-enhanced, t1-weighted mr images to delineate cerebral venous anatomy, along with careful stereotactic planning of the lead trajectory to avoid injury to venous structures. Reported event: one (b)(6) female patient with parkinson¿s disease (pd) had a second lead implanted on the contralateral side six months after having a right subthalamic nucleus (stn) deep brain stimulation (dbs) lead implanted with good results. The reporter stated that the patient had been discharged on postoperative day 1 after an uncomplicated hospital course. The patient reportedly experienced aphasia and a decreased level of consciousness the evening following the second lead implantation. The patient¿s symptoms reportedly persisted through the following morning and the patient was then brought to the emergency room. The reporter stated that except for significant but incomplete expressive dysfluency and disorientation, the patient was neurologically intact. It was noted that a ct scan of the patient¿s head demonstrated cerebral edema and subcortical hemorrhage surrounding the superficial aspect of the dbs lead. The patient was reportedly managed conservatively by having the head of the patient¿s bed elevated to optimize venous return, controlling blood pressure to minimize secondary subcortical hemorrhage, administration of prophylactic anticonvulsants to diminish the known risk of seizure when subcortical hemorrhage is observed, avoiding dehydration to optimize blood rheology, avoiding steroids. It was noted that the patient was appropriately monitored and had adequate supervision. The patient¿s dysphasia reportedly improved over the next several days. It was noted that some of the confusion persisted for several weeks, but the patient¿s speech and cognition ultimately recovered completely. The reporter stated that the complication could clearly be attributed to inadequate avoidance of surface veins. It was noted that the patient experienced improved motor function with dbs despite the subacute postoperative complications. Further information has been requested; a supplemental report will be submitted if additional information is received.

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« Reply #165 on: March 28, 2014, 12:58:37 PM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported the patient had their first programming episode in the doctor¿s office and they had a good response with mobility but they also complained of nausea. It was noted the patient had a lot of nausea, discomfort, and ¿lots and lots of dyskinesia,¿ especially freezing and ¿hypernicity. ¿ it was noted the health care professional (hcp) ¿backed it way down again¿ and then incremented it up but the side effects never went away. It was stated the patient¿s nausea and abdominal fullness and gassiness got worse and worse. It was noted the patient saw their hcp on (b)(6) 2013. It was noted they had tried several different sites. It was noted at the beginning of (b)(6) 2014 the patient did not have any dyskinesia but their movement ¿wasn¿t terrific and they still had a lot of freezing, horrendous gastroparesis, bloated stomach, intestinal bloating after eating, miserable all of the time, and they constantly tried to have a bowel movement. ¿ it was noted the hcp did not think the vagus nerve was stimulated. It was noted after the patient took their medications, they had very slurred speech ¿like they were drunk¿ and they could barely walk. It was stated all of the patient¿s symptoms had gone on since (b)(6) 2013. It was stated the patient had constipation. It was noted the patient saw their hcp about every two weeks to adjust programming but it did not work well.

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« Reply #166 on: March 28, 2014, 12:59:45 PM »

Model Number 37603
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported that the patient was in the emergency room for seizures. It was noted that the patient went to turn off the implant and patient soon had a seizure after implant was turned off. The implant was turned back on but the patient had aphasia and was having a difficult time speaking but was cognitively there. It was difficult for the patient to get words out at that time. It was noted that this had occurred at 1am on the date of this report. Additional information reported that the manufacturing representative did not have any update. The device was left on and the neurosurgeon was informed of the emergency room visit. It was noted that he did not feel that this was deep brain stimulator related. Additional information was requested but had not been received as of the date of this report. Additional information received reported the healthcare professional did not feel the seizure was related to the deep brain stimulator because, the patient turns stimulation off and on all the time and had never had a problem before. Patient turned stimulation on every morning. It was noted that felt that if it was related to the deep brain stimulator this would have happened before. It was noted that this had only happened once per the staff talked to at the hospital. Manufacturing representative had no information about whether patient had a history of seizures but would contact the healthcare professional to inquire. Additional information received reported the patient had no history of seizures and she had never seen seizures related to a deep brain stimulator implant. Reference manufacturer¿s report number: 3004209178-2014-03023.

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« Reply #167 on: March 28, 2014, 01:00:18 PM »

Model Number 37602
Event Date 08/08/2013
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported, the patient had a brain bleed the day after their left implant was put in. It was stated, the patient was not finishing their sentences. It was noted, it had ¿turned out to be worse¿ so the patient stopped talking and the brain bleed healed on its own. It was noted, the patient would go in for the right side deep brain stimulation (dbs) implant soon. It was noted, the patient was going to have an mri performed and it was related to the implantable neurostimulator (ins). It was noted, the mri would be performed before the right side ins was put in. It was further reported, the patient had a rough couple of weeks following the unilateral surgery. It was noted since then the patient had recovered and they were doing well.

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« Reply #168 on: March 28, 2014, 01:00:50 PM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported that the patient had developed some speech problems and she could tell people had a hard time understanding her. The patient also noted that she was apathetic and bored a lot. However, the patient looked forward to social interactions with friends and neighbors and enjoyed listening. Additional information reported that the patient felt awful one year after surgery. The patient was having mood swings, sleeping way too much, grumpy, and depressed. The patient wrote that this had been going on for months and it was getting worse. It was noted that the patient¿s motor symptoms were okay, but the patient was miserable. The patient was convinced that the surgery or settings were to blame. The patient even found herself having suicidal thoughts, but figured ¿she would screw it up and make herself worse. ¿ the patient began to regret having the surgery. The patient received an email from another patient who had the same surgery and was experiencing similar personality changes. The patient discovered that the settings could be causing her depression and was told to find a ¿good programmer immediately. ¿ the patient made an emergency appointment with a neurologist who could adjust her settings, but he did not think the depression was related and suggested a psychiatrist and antidepressants. The patient tried a couple of antidepressants, but they made her feel worse. The patient eventually found a doctor who would adjust the settings and made an appointment. The patient stated that the doctor ¿moved her settings up to a different spot on the stems in her brain and within a few days the difference was amazing. ¿ the patient had more energy, felt more sociable, and the depression was gone. The patient¿s gait was almost normal, the morning tremor in her right hand was gone, and the rigidity and slowness she got every afternoon was gone. The patient noted that she still had some speech issues; she dropped consonants or spoke too softly or quickly.

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« Reply #169 on: April 10, 2014, 05:36:39 AM »

Event Date 11/29/2013
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v455934, implanted: (b)(6) 2010, product type lead; product id 3389s-40, lot # v455934, implanted: (b)(6) 2010, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 37642, serial # (b)(4), product type programmer, patient. (b)(4).

 
Event Description
It was reported that on (b)(6) 2013 the patient¿s implantable neurostimulator (ins) went dead and he did not get a warning. The patient was taken by ambulance to the hospital. The patient stated that he went to the healthcare provider¿s (hcp) office ten days before the ins failed without warning. The patient stated that it went ¿boom / completely dead. ¿ the patient stated that he was paralyzed, could not move his head, speak, or barely breathe. The patient noted that he had to have emergency surgery to replace the ins.

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« Reply #170 on: April 10, 2014, 05:51:15 AM »

Model Number 37612
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Concomitant medical products: product id 37085-40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389s-40, lot# v297034, implanted: (b)(6) 2009, product type: lead; product id 37601, serial# (b)(4), implanted: (b)(6) 2009, product type: implantable neurostimulator; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389s-40, lot# v222841, implanted: (b)(6) 2009, product type: lead; product id 3389s-40, lot# v494243, implanted: (b)(6) 2010, product type: lead; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37651, serial# (b)(4), product type: recharger; product id 3389s-40, lot# v494243, implanted: (b)(6) 2010, product type: lead. (b)(4).

 
Event Description
It was reported that the patient had a globus pallidus lead hooked up the right clavicular rechargeable device and a subthalamic nucleus lead hooked up to the left clavicular primary cell device. The patient was seen due to routine programming. There was poor globus pallidus outcome. The globus pallidus therapy was turned off due to side effects. It was noted that the patient still needed to recharge if the device was off. It was noted that the subthalamic nucleus was fine with no issues. (b)(6) 2014 lfc (hcp): additional information received reported the cause of the event was a misplaced globus pallidus lead or right brain. The lead was not in target, the right globus pallidus was planned. Patient had a brain mri in (b)(6) 2013 that showed the lead on the right was misplaced. The subthalamic nucleus was reprogrammed to optimize therapy and globus pallidus was turned off, (b)(6) 2013. Signs and symptoms associated with the event were slurred speech, severe muscle spasms, imbalance, and swallowing problems. The patient had not required hospitalization. Patient outcome was serious injury/ illness, recovered without sequelae. The patient had bilateral subthalamic nucleus that were effective stimulation. Side effects resolved when turned off the right lead and reprogramming the subthalamic to optimize therapy results.

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« Reply #171 on: May 11, 2014, 06:23:05 PM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
(b)(4).
Event Description
It was reported that the patient experienced acousma before implantation. It was noted that the after implant the patient experience d ¿an intensity, doubtful, talk nonsense, walking quickly, and sound low. ¿ it was noted that a ct scan on 2014-(b)(6) showed that the patient effect was well and the patient was given some psychoactive drug. It was noted that on 2014-(b)(6) the patient went to a psychiatry clinic and the health care professional (hcp) there also gave some psychoactive drug and the effect improved. It was noted that on 2014-(b)(6) the patient did not recognize the family member and had gatism. It was noted that there was no patient injury or death.

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« Reply #172 on: May 11, 2014, 08:47:59 PM »

Model Number 37603
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported a deep brain stimulator (dbs) lead was removed for complaints of dysarthria and the magnetic resonance image (mri) found a cystic structure at the electrode tip. It was noted the brain electrode was removed with no adverse sequelae. It was noted the patient¿s speech had improved and their dystonia was still treated by the contralateral electrode.
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # va00ucg, implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension. (b)(4).

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« Reply #173 on: May 12, 2014, 02:54:38 AM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).
Event Description
It was reported the patient¿s deep brain stimulation (dbs) device was implanted (b)(6) of 2012 and they could never program it. The leads were implanted and ten days later they put the battery pack in and they waited another ten days before they turned it on to program it. The patient¿s healthcare provider (hcp) could not figure out why on the lowest setting the patient could not talk, his left arm would come up to his chest when he would walk and his right shoulder kept twitching or spasming. From the time it was implanted the device did not really function for the patient; every time they turned it on and gave him medications to try to control the dyskinesia it did not work and this was after a year of oral medication. It was noted the patient was dyskinetic the entire time the device was implanted. It stayed in for about a year until they could not figure out why or what was going on. Every time the patient turned it on ¿patient shoulder would, he was falling three times a day. ¿ the patient fell in his house and broke his ribs the last saturday in (b)(6) 2012. The patient¿s dbs device was turned off and he was better but he still had some of the dyskinesia and had tremendous headaches. In (b)(6) of 2013, the patient had his device removed as he could not handle it anymore. The patient was sure there was a short circuit or something like that which caused the dyskinesia. It was reported the patient thought the leads down in the globus thalamus would not do that, he understood it may affect his speech, but not the rest of it. It was reported the device was leading to such headaches and such problems; he had a big bony growth behind his ear in his skull which was occurring during the entire time the device was implanted. After the device was removed those symptoms went away. Additional information received two weeks later reported somewhere around the second week of (b)(6) 2012 the patient was in severe dyskinesia one night and he could not turn it off. He did not know what was going on and he finally got in touch with a manufacturer representative from (b)(4) who walked his wife through turning his device off. It was also reported the patient¿s unit did not come out easily, the leads and all that stuff did not come out easily. Additional information has been requested but was not available as of the date of this report; a follow-up report will be sent if information becomes available.

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« Reply #174 on: June 07, 2014, 10:10:51 AM »

Model Number 7426
Event Date 06/29/2009
Event Type Injury Patient Outcome Other
Event Description
It was reported the patient had a serious adverse event of expressive aphasia. The event was related to the surgery. An unknown intervention was done and the event was noted as resolved.

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« Reply #175 on: June 07, 2014, 10:11:46 AM »

Model Number 37612
Event Date 02/20/2014
Event Type Injury Patient Outcome Hospitalization
Manufacturer Narrative
(b)(4).
Event Description
It was reported that there were 1-2 bad electrodes isolated to one side of a bilateral deep brain stimulation (dbs) system. The patient was recharging often and there was high current drain with low impedance. The manufacturer¿s representative had met with the patient the day prior to report to perform impedance testing. Electrode impedances were as follows: c/0 745, c/1 734, c/2 952, c/3 1080, 0/1 44, 0/2 844, 0/3 1125, 1/2 844, 1/3 1125, 2/3 1035. The patient was currently in the hospital for bad gait and speech problems. The patient had been hospitalized for 10 weeks. Extensive reprogramming had been performed by the neurologist and only programming electrodes 0 and 1 seemed to help the patient. The patient was programmed on the shorted contact. It was stated that the patient¿s system was fine prior to hospitalization.

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« Reply #176 on: August 10, 2014, 06:40:07 AM »

Model Number 37601
Event Type Injury Patient Outcome Hospitalization
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 3389s-40, lot# va023l5, implanted:(b)(6) 2012, product type: lead. Product id: 3389s-40, lot# va08klm, implanted: (b)(6) 2013, product type: lead. (b)(4).

Event Description
It was reported that there was a stimulation/therapy issue, patient was complaining of sudden speech slurring. The action required as a result of the event was reprogramming and hospitalization. No diagnostic testing or troubleshooting was performed but would be in the future. It was unknown if the issue was resolved or if the cause of the issue was determined. Patient had a sudden increase in slurring of their speech and had gone to the hospital. The hospital tests had come back negative. Patient¿s husband wanted to lower stimulation and lowered both sides by about 1 volt, the patient had tolerated this well. Two hours after the change the patient was doing fine and had been released from the hospital. A follow-up visit was being scheduled to check impedances and reprogram if necessary. The patient was alive with no injury.

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« Reply #177 on: August 10, 2014, 06:40:35 AM »

Model Number 37603
Event Date 07/24/2013
Event Type Injury Patient Outcome Hospitalization,Life Threatening,Disability Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0935y, implanted: (b)(6) 2013, product type: lead. (b)(4).

Event Description
It was reported that the clinical diagnosis was intraparenchymal hematoma. It was noted that the event was related to the procedure. It was noted that a post-op ct showed 2x1 cm intraparenchymal hemorrhage along the electrode tract. It was noted that there was mild hemiparesis/motor apraxia, dysarthria, dysphagia, and speech apraxia. It was noted that there was in-patient hospitalization. It was noted that there was prolongation of existing hospitalization. It was noted that actions taken included occupational and speech therapy. It was noted that the event resolved with sequelae on (b)(6) 2013.

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« Reply #178 on: August 10, 2014, 06:41:08 AM »

Model Number 37603
Event Date 07/03/2013
Event Type Injury Patient Outcome Disability,Other
Manufacturer Narrative
Product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3387s-40, lot# va09prb, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4, implanted: (b)(6) 2013, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer. Patient product id: 3387s-40, lot# va04pwk, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
It was reported that when the healthcare provider (hcp) did the second surgery on (b)(6)2013 and was implanting the leads he nicked a vein, which caused the patient to experience stroke like symptoms. The patient had cognition, speech, and balance issues that he was still experiencing at the time of the report. The hcp informed the reporter that he ¿deemed the surgery a fail. ¿ the hcp was aware that the patient was still having issues. The reporter stated that the patient was ¿somewhat of a medical nightmare. ¿ a week later, it was reported that there was 50% or greater symptom reduction. The lead was involved in the event as the patient had a venous infarct after the right lead was placed. The patient had cognitive deficits, balance issues, and slurred speech. A ct scan and mri were taken. Physical therapy, occupational therapy, and speech were all instituted. The cause of the issue was post-operative complications and it was not device related. The patient recovered with permanent impairment on (b)(6) 2014 with a cortical venous infarct. The patient¿s parkinson¿s disease symptoms were much improved after surgery. However, the patient had some new persistent neurological compromise two degrees to the venous infarct.

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« Reply #179 on: September 06, 2014, 01:57:49 AM »

Model Number 37603
Event Type Injury Patient Outcome Other
Event Description
It was reported that the patient had had balance issues and trouble with speech since implant. It was noted that the patient had fallen a couple of times. Initially it was thought that the patient¿s medication was off but he had been off the medication and was still having problems. Patient had been instructed to turn stimulation down and had further programming appointment scheduled for the friday following the date of this report. Patient¿s stimulation was down from 3. 30 and 4. 10 to 3. 0 and 3. 40. Patient¿s status was unknown. It was later reported that there was disappointment and dissatisfaction expressed about the therapy as far as what had been sold and presented to them prior to implant and what had happened in reality. Patient had tremors prior to the deep brain stimulator implant. Patient had been pretested and it had worked for him. Almost 2 months after implant the patient had a lot of issues. Patient¿s quality of life had not increased. Patient had an appointment scheduled for (b)(6) 2014. Patient was experiencing symptoms. It was noted that the patient had expected it to be an outpatient surgery and instead patient had spent 10 days in rehab. The patient had been told about the risk of infection and stroke but nothing else. The patient had been trained on using the patient programmer but did not know what to do with it. The patient was not very discouraged and not positive. The patient was not enjoying things in life anymore. It was noted that prior to deep brain stimulator surgery the patient had only had some tremors and had not been that advanced with parkinson¿s disease symptoms. The deep brain stimulator surgery was supposed to make the patient better but had made him worse. Patient was not able to return to his physical job. Patient¿s symptoms were change in gait, lethargy, and seizures. It was further noted that the manufacturing representative had been there when the patient had a seizure and the representative had come to rehab. The patient had had a seizure right after surgery at the hospital on the date of implant. At rehab the patient had been completely out of it and had been unresponsive. The healthcare professionals were blaming it on medications. Patient was put on 4 different seizure medications, one being dilantin. Patient no longer took seizure medication. Patient was unresponsive and was sent for a computerized tomography scan (cat scan) which had determined the patient had seizures and that was when patient was put on seizure medications. The healthcare professionals had stated ¿oh no, he should be responsive. ¿ it was noted that nobody seemed to know what was going on. They had come for physical therapy and were not able to wake him up, he had been completely out of it. An electroencephalogram (eeg) was done and had not found anything particular. Following deep brain stimulator surgery patient had the following symptoms: speech issues, gait issues, balance problems, patient had fallen several times, extremely tired, swallowing issues, patient looked at food as if he did not know how to put a fork into it, and patient looked like he had aged (b)(6). Patient used to work full time, go to ymca 3 times a week and drove a car, patient was no longer able to drive or do anything. It was hard to leave the patient alone. It was believed that symptoms were device related because patient had no chemicals in his body except some medication for parkinson¿s and it was not a lot. Healthcare professionals stated they had never seen those symptoms after a deep brain stimulator surgery. Patient was told that this kind of reaction was very common and it might take 6 months to a year to recover from the surgery. Patient had been given a limit on the patient programmer and could not go beyond ¿4 or something. ¿ patient had been adjusting therapy all the time on his own. Patient got better here and there but still had a lot of issues going on and was no longer positive. Patient was scheduled to see the healthcare professional on friday following the date of this report. Additional information received reported the patient was having some gait and speech issues related to programming. Patient had primary tremor with parkinson¿s and as the patient would get tremor control he would get some speech issues. The patient had since been reprogrammed to a bipolar setting and although he had a little bit of a breakthrough tremor his balance was better and so was his speech the last time the manufacturing representative had spoken to the patient. It was unknown if there were any other updates. The manufacturing representative had been involved with the patient through rehab. It was noted that the patient¿s family was anxious about getting the patient¿s progress and getting him programmed so he could go back to work. As of the week prior to the date of this report the patient was doing better and was planning on returning to work. Additional information received reported the alleged seizure was not the reason for rehab and all of their patient¿s go through a rehab cycle. Seizure was not confirmed and had been discussed after the fact. The patient was having some cognitive issues after the battery placement that had led the healthcare professional to believe it may have been a seizure. Patient had been placed on seizure medication and had not had any seizure activity after the first alleged one. Additional information was requested but had not been received as of the date of this report.
Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3389s-40, lot# va0jcu8, implanted: (b)(6) 2014, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3979081
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